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Completed

NCT Number: NCT06431568

Ondansetron Prior Spinal Anaesthesia

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

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Key information

Conditions

Sex eligibility

Female

Study type

Observational

Primary location

Assiut university faculty of medicine

Asyut, Egypt

About this study

Hypothesis:

Administration of ondansetron prior to spinal anesthesia can attenuate hypotension and bradycardia.

Aim:

Since Ondansetron is commonly used during cesarean deliveries to treat nausea and vomiting, this study will observe the correlation between ondansetron administration and effect on hemodynamics in order to confirm that the use of Ondansetron can reduce incidence of hypotension and bradycardia associated with spinal in cesarean section, and to identify the optimal timing and dose for administration.

Objectives:

  • Primary outcome: incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron and those who did not
  • Secondary outcome : use of vasopressors , bradycardia , timing of administration of Ondansetron wether it is more or less than five minutes prior to the administration of anesthesia.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant patients undergoing elective caesarean section

Exclusion criteria

  • Preeclampsia
  • Eclampsia
  • Hypertension
  • Diabetes

Treatment and study plan

Primary outcomes

  1. Blood Pressure

    Time frame: one hour

    incidence of hypotension after spinal anaesthesia in the patients who received Ondansetron

Secondary outcomes

  1. Heart rate

    Time frame: One hour

    Incidence of bradycardia after ondansetron

  2. Vasopressor

    Time frame: One hour

    Incidence of use of ephedrine or phenylpherine

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Collaborators

  • Kuwait Institute for Medical Specialization

Registry information

Official study title

Effect of Prophylactic IV Ondansetron Prior Spinal Anaesthesia in Caesarean Section on Bradycardia and Hypotension (Observational Study)

Acronym: Ondansetron

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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